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More than 112,000 bottles of Amazon-branded extra-strength acetaminophen are being recalled after consumers reported discolored pills, according to the Food and Drug Administration (FDA).
Aurobindo Pharma USA, a New Jersey-based pharmaceutical company, initiated the voluntary recall on Sept. 18, affecting three bottle sizes of Amazon Extra Strength Acetaminophen 500 mg caplets.
The recall remains ongoing, according to the FDA.
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The recall covers 14,640 bottles containing 200 caplets, 90,456 bottles containing 500 caplets and 7,836 bottles containing 1,000 caplets.
The FDA said the recall was prompted by consumer complaints involving discolored tablets.
Information provided by the FDA does not identify the cause of the discoloration.
Amazon confirmed the voluntary recall, saying it was working with the manufacturer and federal regulators.
“Amazon is voluntarily recalling specific lots of Amazon Basic Care Extra Strength Pain Relief acetaminophen 500mg caplets due to reports of tablet discoloration in the affected lots,” an Amazon spokesperson told FOX Business.
“This is a voluntary recall initiated in coordination with the manufacturer, Aurohealth, and the FDA.”
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The agency also did not describe any specific health risks or say whether any injuries have been reported in connection with the recall.
The affected lot numbers for the 200-count bottles are ACD125040A; for the 500-count bottles, ACD124036A, ACD124030A, ACD124042A, ACD124048B and ACD125010A; and for the 1,000-count bottles, ACD124048A.
The affected products were manufactured in India and distributed by Amazon.com Services LLC, based in Seattle, Washington.
The recall follows a separate voluntary recall initiated Sept. 3 by India-based Inventia Healthcare Ltd. involving 13,567 bottles of 25-milligram chlorthalidone tablets that failed to meet dissolution specifications, according to the FDA.
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FOX Business has reached out to Aurohealth for comment.
